Lurbinectedin

As the most malignant subtype of lung cancer, small cell lung cancer has long been faced with the clinical dilemma of extremely limited second-line treatment options. The advent of lurbinectedin has brought a brand-new treatment option for this group of patients. This drug is an ecteinascidin derivative cytotoxic drug, which specifically binds to the minor groove of the DNA double helix to inhibit the transcriptional activity of RNA polymerase II, and simultaneously induces apoptosis of tumor cells. In addition, it also has a regulatory effect on macrophages in the tumor microenvironment. At present, its core indication is metastatic small cell lung cancer with disease progression during or after platinum-containing chemotherapy. It is the first innovative single-agent regimen approved for second-line treatment of small cell lung cancer in the past 25 years, providing a treatment path that balances efficacy and safety for relapsed patients who cannot tolerate combined chemotherapy.

The global market size of lurbinectedin exceeded USD 210 million in 2022, with a year-on-year growth of more than 32% in 2023. The main driving factors are the rigid demand for later-line treatment of small cell lung cancer and its expanded application in other solid tumor fields. The domestic market is currently in the introduction stage. Since the patent of the originator drug has not yet expired, only the originator product has been approved for marketing, and no generic drug has entered the market. With the popularization of treatment specifications for small cell lung cancer, it is expected that the annual compound growth rate of the domestic market size will remain above 40%.

The originator enterprise of lurbinectedin is PharmaMar, a Spanish company, and the trade name of the originator drug is Zepzelca. Its US compound patent will expire in 2037, and the core compound patent in China will expire in 2035. At present, the main approved dosage form is injection with a specification of 4 mg per vial. The originator dosage form has been included in the FDA Reference Listed Drug Catalog, and has also been included in the China Listed Drug Catalog. As of the retrieval time, there is no approved lurbinectedin generic drug preparation in China, and no A-status registration number submitted by any enterprise is available on the CDE API registration platform. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for lurbinectedin API. Most of the products are available in stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All products meet the requirements of the Chinese Pharmacopoeia, FDA and other national regulations, and can provide stable reference standard support for relevant pharmaceutical enterprises in the whole process of API R&D, quality research and preparation declaration.